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Process qualification is the qualification of manufacturing and production processes to confirm they are able to operate at a certain standard during sustained commercial manufacturing. Data covering critical process parameters must be recorded and analyzed to ensure critical quality attributes can be guaranteed throughout production. [ 1 ]
IEEE software life cycle; Software project management; Software quality assurance; Software requirements specification; Software configuration management; Software design description; Software test documentation; Software verification and validation; Software user documentation; Software reviews and audit
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [ 1 ]
Business Process Validation (BPV) is the act of verifying that a set of end-to-end business processes function as intended. If there are problems in one or more business applications that support a business process, or in the integration or configuration of those systems, then the consequences of disruption to the business can be serious.
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
The software development process is a typical application of Fagan inspection. As the costs to remedy a defect are up to 10 to 100 times less in the early operations compared to fixing a defect in the maintenance phase, [1] it is essential to find defects as close to the point of insertion as possible.
Process performance qualification protocol is a component of process validation: process qualification.This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
Software validation checks that the software product satisfies or fits the intended use (high-level checking), i.e., the software meets the user requirements, not as specification artifacts or as needs of those who will operate the software only; but, as the needs of all the stakeholders (such as users, operators, administrators, managers ...